FDLI Food and Drug Policy Forum, July 25, 2012
15 Pages Posted: 23 Jul 2012 Last revised: 25 Nov 2014
Date Written: July 25, 2012
Tucked into the America Invents Act is the first statutory exemption for any patentable subject matter. Section 33 renders unpatentable all claims “encompassing a human being.” By recognizing a vague subject matter – exception for human beings despite the fact that internal policies had long militated against such patent claims, Congress has politicized the patent law to an unheard-of degree. While textually consistent with internal USPTO policy, the passage of § 33 should not be seen as an invitation to litigators to expand § 101 unpatentable-subject-matter challenges to validity by including arguments that medical methods, genetic tests, biological chimeras, or emerging cell and tissue therapies are now unpatentable, particularly in light of the recent Prometheus Supreme Court decision. The Federal Circuit’s recent decision in CLS Bank undercuts this argument. As the U.S. Court of Appeals for the Federal Circuit and the U.S. Supreme Court have both long held, living subject matter is a valuable part of the United States’ biotechnology industry. This exception is limited to only those patents that encompass an entire human being, thus exempting patents on genetic modifications to cells, tissues, organs, bones, genes, zygotes, and treatments. Only then can we ensure innovation, certainty, and profitability in the lucrative and promising area of biotechnology, ensure that the United States remains competitive in the international market, and recognize that it is not the province of the Patent and Trademark Office or the patent laws to be embroiled in a political conflict that is irrelevant to innovation.
Keywords: AIA, America Invents Act, Prometheus, CLS Bank, Section 101, Section 33, Human Organism, Biotechnology, Cloning, Clone, Right-to-Life, Abortion, Zygotes, Chimera, gene, bone, organ, cell and tissue engineering, stem cell, genetic modification, gene
Suggested Citation: Suggested Citation
Stroud, Jonathan, Politicizing Patents - Patenting Biotechnology in the Wake of Section 33, Prometheus, and CLS Bank (July 25, 2012). FDLI Food and Drug Policy Forum, July 25, 2012; American University, WCL Research Paper. Available at SSRN: https://ssrn.com/abstract=2115557 or http://dx.doi.org/10.2139/ssrn.2115557